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A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

NCT01014975 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-10-21

Study results available
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Summary

This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.

Conditions

  • Acute Ischemic Stroke

Interventions

BIOLOGICAL

Plasmin (Human)

Plasmin (Human), 20 mg, delivered through a catheter into a thrombus

BIOLOGICAL

Plasmin (Human)

Plasmin (Human), 40 mg, delivered through a catheter into a thrombus

BIOLOGICAL

Plasmin (Human)

Plasmin (Human), 80 mg, delivered through a catheter into a thrombus

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Jeffrey Saver, MD · University of California, Los Angeles

  • Peter Mitchell, MD · Melbourne Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-11-30
Completion
2014-02-28

Countries

  • Australia
  • Austria
  • France
  • Serbia
  • Slovakia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01014975 on ClinicalTrials.gov